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Stitch or device? trial tests which groin closure leaves heart patients more comfortable

NCT ID NCT07814144

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Doctors close the groin vein puncture after atrial fibrillation ablation either with a suture-based device called Perclose ProGlide or with a traditional figure-of-8 stitch. This trial randomly assigns 90 adults to one of the two methods and asks them how satisfied they are with the closure. Researchers also track how quickly bleeding stops, how soon participants can walk, when they go home, and whether any vascular complications appear within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Perclose ProGlide suture-based venous closure device
What this could lead to
If the device proves more comfortable and faster than a stitch, it could become a routine way to close groin vein access after heart rhythm procedures.
What could go wrong
This is a small, single-center study of 90 people, so its results may not hold for other hospitals or patients. Both methods are already used in practice, and the main measure is a satisfaction questionnaire rather than a hard clinical outcome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

90 people

The number who actually took part.

Started

Jan 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥19 years or legal age to provide informed consent under Korean law. 2. Scheduled for atrial fibrillation catheter ablation using unilateral femoral venous access with a sheath ≥8 Fr. 3. Bilateral femoral venous anatomy suitable for application of the Perclose ProGlide™ suture-based vascular closure device. 4. Written informed consent and agreement to post-procedural follow-up and outpatient visits. 5. Considered able to complete follow-up during the study period. Exclusion Criteria: 1. History of prolonged hospitalization due to vascular access-related complications. 2. History of vascular surgery involving the lower extremities or aorto-iliac axis. 3. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state). 4. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy. 1\. History of prolonged hospitalization due to vascular access-related complications. 2\. History of vascular surgery involving the lower extremities or aorto-iliac axis. 3\. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state). 4\. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yonsei University College of Medicine

    Seoul, South Korea

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Other studies related to the condition(s) this trial covers.